111-201-02 - PlutoX Series User's Manual - A0

Digital Intra-oral X-Ray Imaging System
Pluto0001X /Pluto0002X
User's Manual
Document Version: A0
Document ID: 111-201-02
Release Date: 2019-11-25
Before operating, please read this user manual and pay attention to all safety precautions.
Please ensure that this user's manual is properly maintained so that it can be accessed at any time
(reserve).
Please use it correctly on the basis of full understanding of the content.

Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
To Customers
Congratulations on your purchase of the Pluto0001X/Pluto0002X Digital Intro-oral X-Ray Imaging
System (Hereinafter referred to as Pluto0001X/Pluto0002X) which is manufactured by iRay
Technology Co. Ltd. (Hereinafter referred to as iRay).
At iRay, we strive to not only make the world-class products that deliver the good value
possible to our customers but also offer the highest quality of service and customer care.
Please take time to read through this user guide in order to utilize the product effectively.
We hope you enjoy the experience with iRay Pluto0001X/Pluto0002X.
If you have any questions or suggestions, please feel free to contact us.
Service Office
Tel: +86 21 50720560
Fax: +86 21 50720561
E-mail: [email protected]
Location: No.33 Xinggang Road, Taicang Port Economic and Technological

Development Zone, Jiangsu, China
Caring for your environment

This symbol indicates that this product is not to be disposed of with your residential or
commercial waste.
Recycling iRay Equipment

Please do not dispose of this product with your residential or commercial waste. Improper handling of
this type of waste could have a negative impact on health and on the environment. Some countries or
regions, such as the European Union, have set up systems to collect and recycle electrical or electronic
waste items. Contact your local authorities for information about practices established in your region. If
collection systems are not available, call iRay Customer Service for assistance.
Disclaimer
iRay shall not be liable to the purchaser of this product or third parties for any damage, lose, or injury
incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of
this product.
iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs,
or alterations to this product or failure to strictly comply with iRay’s operating and maintenance
instructions.
iRay shall not be liable for any damage or loss arising from the use of any options or consumable
products other than those dedicated as Original iRay Products by iRay Technology.
Information regarding specification, compositions, and appearance of this product is subject to change
without prior notice.。
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Copyright
All rights reserved
No part of this publication may be reproduced in any form or by any means without the written
permission of iRay. The information contained herein is designed only for use with iRay
Pluto0001X/Pluto0002X.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co.Ltd.
Symbols and Conventions

The following symbols and conventions are used throughout the user guide.
This symbol is used to identify conditions under which

improper use of the product may cause death or serious
personal injury.
This notice is used to identify conditions under which

improper use of the product may cause minor personal
injury.
This notice is used to identify conditions under which

improper use of the product may cause property damage.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be performed.
This is used to indicate important operations and

restrictions.
This is used to indicate operations for reference and

complementary information.
Labels and markings on the equipment
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The contents of the labels and markings on iRay Pluto0001X/Pluto0002X product are
indicated below:
Symbol Guide
Caution: please refer to the instructions in the user manual.
This symbol is used to identify the manufacture’s series number

which is after, below or adjacent to the symbol. The series number of
iRay products is usually made of 19 digits as shown below:
Numerical Order
Date
Location
Version
Derivative type
Product type
This symbol is used to indicate the name, address of the

manufacturer.
The date of manufacture, as well as the name and address of the
manufacturer, is combined in this symbol.
This symbol is used to indicate the name and address of iRay

authorized representative in the European Union.
This symbol is used to indicate consultation of the user guide for

general information.
Safety Signs: please refer to the user guide for safety instructions.
Use-by date, Indicates the date after which the medical device is not
to be used.
Type BF applied part
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IP68 IP Grade of the sensor(detector) according to IEC60529
Caution: Federal law restricts this device to sale by or on the order of

Rx only a physician.
Package symbol, fragile, handle with care
Package symbol, keep away from rain
Package symbol, keep away from sunlight
Package symbol, keep the way up, it shows the correct upright
position of the distribution packages for transport and storage.
Package symbol, stacking limit by number, it shows the maximum

number of identical transport package which may be stacked on the
bottom one, where “n” is the limiting number.
Package symbol, indicates the package shall be stored, transported,

and handled within temperature limits.
Package symbol, indicates the range of humidity to which the

medical device can be safely exposed.
This symbol indicates the item is a medical device.
Unique Device Identifier

This symbol indicates a carrier that contains Unique Device
Identifier information
This symbol is used to indicate that the equipment has passed.

CE testing and it is followed by the CE Notified Body number.
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Contents
TO CUSTOMERS ...................................................................................................................................... 1
1. Safety Information ............................................................................................6

1.1 Safety precautions..................................................................................... 7
1.2 Notes for Using ........................................................................................ 8
1.3 Storage and Operation Environment .......................................................... 9
2. General Introduction .......................................................................................10
2.1 Indications for Use ................................................................................. 11
2.2 Component of the imaging system ............................................................ 11
2.3 Timing and Electrical characteristics ....................................................... 13
2.4 AED trigger sensitivity ........................................................................... 14
2.5 PC configuration .................................................................................... 15
3. Information on Operation................................................................................17
3.1 Installation and operation ....................................................................... 18
3.2 Multi-sensor(detector)............................................................................. 18
3.3 Connect Sensor(detector) ........................................................................ 18
3.4 Get the first image .................................................................................. 19
3.5 Create correction templates:.................................................................... 20
3.6 Load template......................................................................................... 21
3.7 Defect template modification ................................................................... 22
4. Troubleshooting ..............................................................................................24
4.1 Log..………………………………………………………………………..25
4.2 Quick troubleshooting ............................................................................. 25
5. Information on Safety Regulations .................................................................26
5.1 Medical Equipment Safety Standards........................................................ 27
5.2 Guidance and manufacture’s declaration for EMC .................................... 28
5.3 Environmental Directive ......................................................................... 29
6.Product Maintenance........................................................................................30
6.1. Expected Service Life ............................................................................. 31
6.2. Regular Inspection and Maintenance ...................................................... 31
6.3. Repair ................................................................................................ 31
6.4. Care and Cleaning .............................................................................. 32
Appendix .............................................................................................................33
A. Information of Manufacture ................................................................. 34
B. Recommended exposure time ............................................................... 35
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1. Safety Information
1.1 Safety precautions..................................................................................... 7

1.2 Notes for Using ........................................................................................ 8
1.3 Storage and Operation Environment .......................................................... 9
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1.1 Safety precautions

Follow these safeguards and properly use the equipment to prevent injury and damage to any
equipment/data.
WARNING
Installation and Do not use or store the equipment near flammable chemicals such as thinner,
benzene, etc.
environment of use
If chemicals are spilled or evaporate, it may result in fire or product damage
through contact with electric parts inside the equipment.
Do not connect the equipment with anything other than specified.
Doing so may result in personal injury or product damage.
Do not install or use in the following environment, or it may cause fire, personal
injury or product damage:
Facilities near water sources
In direct sunlight
Close to air condition or ventilation
Dusty to a heat source as a heater
In a salty or acidic environment
High temperature and high humidity
Ice or condensation
In the environment easy to vibrate
On a slope or in an unstable area
 Ensure that the cable is not knotted or wound during use. Or it may cause the
equipment damage or personal injury.
WARNING
Handling  Never disassemble or modify the equipment. No modification of this equipment is
allowed.
 Follow the below instructions to prevent damage to the sensor(detector) and
cable
Do not twist, bend, pull and pinch the cable strongly
Do not strike or drop the equipment.
Do not touch the pin of the USB connector
Do not put the equipment and pointed objects together.
When a problem Please unplug the USB connector when a problem happened and contact the
supplier or local dealer:
occurs
 When there is smoke, an odd smell or abnormal sound.
 When liquid has been spilled into the equipment or a metal object has entered
through an opening.
 When the equipment has been dropped and damaged.
Maintenance and  Check the sensor(detector) and cable for any damage or abnormal conditions
inspection  Check that the PC and software are working properly
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CAUTION
Hygienic protection  Hygienic protection
and cleaning The sensor(detector) should be covered with hygiene sheath when you apply the
sensor(detector) to a patient
Note that a hygiene sheath whose is single use only. The bag should be renewed
for each patient to prevent any possible transmission of infective agents.
Use a hygiene bag whose size fit the size of the sensor(detector)
Purchase the medical purpose sheath via formal purchase channels:
Dental Intraoral Camera Sheaths
 Cleaning
Pay special attention to avoid the risk of damage when cleaning the
sensor(detector)
The sensor(detector) should be cleaned frequently. Wipe the sensor(detector) and
the cable with soft cloth which is damped with 70% isopropyl alcohol when the
USB connector is not connected.
Do not apply any liquid or disinfectant to the product except 70% isopropyl
alcohol.
Do not immerse the sensor(detector) in disinfectants or any other chemicals
Do not sterilize the product by heating, autoclaving or UV
CAUTION
No valuable clinical obtained after exposure due to operational reasons or failure
of the device
The sensor(detector) performance was abnormal, no valuable clinical images
obtained after exposure due to the interference of the equipment which is not
conforming to IEC60601-1-2standard.
The sensor(detector) is used in conjunction with the registered x-ray machine.

Installation and software operation of this product, please refer to the product
user’s manual. For the other operation, please refer to the operation manual of the
x-ray machine.
1.2 Notes for Using

When using the equipment, take the following precautions. Otherwise, problems may occur
and the equipment may not function correctly.
Before using
 Please check whether the USB connector is dry or clean before connecting the USB
connector
 Please hold the control box of the USB when plugging the USB connector, do not
touch the pin of USB connector
During using
 Do not move the USB connector during the use of the sensor(detector)
 When the sensor(detector) is working, the temperature of the sensor(detector) will

increase. Please pay attention to the temperature of the sensor(detector) to avoid the
risk of injury.
 The detector should warm up for 15 minutes before exposure or updating the gain map
or defect map.
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During exposure
 Do not move the Cable or Sensor(detector) during exposure, or it may cause image
noise or artifacts, even incorrect images.
 Do not use the devices near the equipment generating a strong magnetic field.
Otherwise, it may cause image noise, artifacts or even incorrect images.
After using
 After the USB port is pulled out, please take care of the USB connector to avoid the
risk of damage.
The sensor(detector) should be stored in a place free of chemicals or gases and free from
adverse factors such as pressure, high temperature, humidity, direct sunlight, dust, oxides or
sulfides.
When the sensor(detector) is out of using, it is recommended to put it into the product
package box, to avoid damage.
1.3 Storage and Operation Environment

Ensure that the sensor(detector) is stored and used in the following environment:
Temperature Barometric Barometric
Temperature Humidity
variation pressure change
Operation 10~35℃ ≤1℃/min 20~90% RH ≤10 mbar/hour

700~1060mbar
Storage -10~55℃ ≤1℃/m in 10~95% RH ≤20 mbar/hour
 Do not operate the sensor(detector) at an altitude more than 3000m， the system connected
with the sensor(detector) also can operate at an altitude less than 3000m.
 Do not expose the sensor(detector) to a hot and humid environment, otherwise it may result in
product damage.
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2. General Introduction
2.1 Indications for Use ................................................................................. 11

2.2 Component of the imaging system ............................................................ 11
2.3 Timing and Electrical characteristics ....................................................... 13
2.4 AED trigger sensitivity ........................................................................... 14
2.5 PC configuration .................................................................................... 15
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2.1 Indications for Use
The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with
dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis
of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by
trained professionals under the guidance of doctors.
This device is not intended for mammography and conventional photography applications.
This device is suitable for providing dental radiography imaging for both adult and pediatric.
According to the expected use of Pluto0001X/Pluto0002X and the result of risk assessment, the product
essential performance is identified: image acquisition of X-ray sensor(detector) and image process.
This manual contains information about Pluto0001X/Pluto0002X. All users should read and understand
this manual before using the product. All information in this manual, including illustrations, is based on
the device prototype. If the device does not contain these contents, they will not apply to this device.
2.2 Component of the imaging system

The component of digital intraoral X-ray imaging system are sensor(detector).
2.2.1 Image acquisition workstation (optional)
The image acquisition software iRayDR (optional) is used to acquire and display the image, patient
management, examination management, image storage and image printing administration.
Note: the detail description of the image acquisition workstation are showed in the user manual of the
iRayDR.
2.2.2 Sensor(detector)
The pluto0001X and Pluto0002X feature a 20 µm pixel pitch CMOS sensor(detector) with directly
deposited CsI:Tl scintillator which ensures optimal resolution. Made from a strong sealed Kevlar shell,
the sensor(detector) has an ergonomic design with smooth edges, rounded corners, and a flexible cable
for maximum patient comfort. An easy to use hi-speed direct USB interface enables a simple
connection to a PC without need for an additional control box. The optional iRay intra-oral software
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application makes it easy to acquire, enhance, analyze, view and share images from the Pluto
0001X/Pluto0002X sensor(detector).
Fig.1 Pluto0001X outline（unit: mm）
Fig.2 Pluto0002X outline（unit: mm）
Technical Specification
Item Detailed information
Pixel matrix 1500×1000 1800×1300
Pixel Pitch 20μm
Scintillation Screen CsI
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Sensor(detector) size 38.5mm×25mm×5mm 40mm× 31mm×5mm
AD Conversion 16bits
Limited: 25lp/mm
Spatial resolution
Typical: >14.5lp/mm
IP68
Ingress Protection (the highest point of enclosures with a height greater than 1000mm
below the surface of water, and the duration of the test is more than 30
minutes)
Sensitivity >50lsb/uGy
Trigger sensitivity <100μGy/s
Max linearity dose >400uGy
Length of cable ＜3m
interface Direct USB, USB2.0
Power <2W
2.3 Timing and Electrical characteristics
Condition Min Type Max Unit

Integration time 0. 05 4 s
Image sensor(detector) head 30 50 mA
Current consumption
USB driver 200 350 mA
Readout time 1 1.5 s
AcqDelay Can be Configured 50 ms
Image cycle time 6 s
 Trigger Mode
One is be triggered by the sensor(detector) automatically, the other is trigged by the software
command by an operator. Software trigger mode is only used for debug and can be used by
service engineer who is authorized by iRay.
Type DC X-tube AC X-tube
Automatically detect Only detect x-ray start;
mechanism
x-ray start and x-ray end x-ray end is pre-set by integration time
Integration time Depend on X-ray width Pre-set and fixed, 0.5s, 1s or 1.5s
 AED(auto exposure detection) mode-DC x-ray tube
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Monitoring Photodiode
X-ray OFF X-ray ON X-ray OFF
Rising up threshold
output
level
Falling down
threshold level
Xray
Time
SPI_CONFIG FDFF CLR CLR CLR Read out image data F3FF CLR Read out image data
0.34ms Light image 1s
0.34ms Integration
Integration
<50ms
AED mode AcqDelay Software mode
Light image Post dark image
 AED(auto exposure detection) mode-AC x-ray tube

Monitoring Photodiode
X-ray OFF X-ray ON X-ray OFF
Rising up threshold
output
level
Xray
Time
SPI_CONFIG FDFF CLR CLR CLR Read out image data F3FF CLR Read out image data
Pre-set Pre-set
0.34ms 1s
0.34ms Integration
Integration
<50ms
AED mode
software mode
Light image Post dark image
 Software mode
XRAY
SPI_CONFIG F3FF F3FF
Time
integration time window integration time window

typical.1s typical.1s typical.1s typical.1s
Rolling CLR Swap transfer Rolling CLR Swap transfer
Exposure
Window
Post dark image

Light image
2.4 AED trigger sensitivity
The AED trigger sensitivity should be matched with X-ray source dose rate(correlated to
power capacity) to achieve the minimum X-Ray width, because the X-Ray during the AED
cycle time will not contribute to the image integration.
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AED Trigger sensitivity Level choose AED cycle time(ms)

50 5.5
200 1.5
The x-ray machine used with intra-oral sensor(detector) in the current is 60-70kV and 1-8mA.
For different type of x-ray machine, it is recommended to select the appropriate trigger
threshold according to the following tables:
SID Min Entrance Recommend Max Entrance mA

Equivalent
kV mA Skull size Dose Trigger Dose
(mm) filter (up to)
Rate(uGy/s) Level(uGy/s) Rate(uGy/s)
2mm Al 256
60 1 250 8mm Al Standard 69 50 1000 4
10mm Al Fat 51
2mm Al 306
65 1 250 8mm Al Standard 91 50 1000 3.2
10mm Al Fat 69
2mm Al 358
70 1 250 8mm Al Standard 226 50 1000 3
10mm Al Fat 90
SID Min Entrance Recommend Max Entrance mA

Equivalent
kV mA Skull size Dose Trigger Dose
(mm) filter (up to)
Rate(uGy/s) Level(uGy/s) Rate(uGy/s)
2mm Al 927
60 3.2 250 8mm Al Standard 251 150 3000 8
10mm Al Fat 186
2mm Al 1115
65 3.2 250 8mm Al Standard 333 150 3000 8
10mm Al Fat 253
2mm Al 1311
70 3.2 250 8mm Al Standard 425 200 4000 8
10mm Al Fat 330
Note: The dose rate may be different between different x-ray machines with same exposure
parameter, which need to adjust according the actual dose rate.
2.5 PC configuration
System Recommand configuration Minimum configuration
CPU：IntelCore i3 (R) CPU：IntelPentium(R) frequency≥

System configuration frequency≥ 2.5G 2.0G
Memory：4GDDR3/4 Memory：4GDDR3/4
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Preview Monitor ：1920×1080 Preview Monitor ：1280×768

Other hardware Support Serial port communication、USB2.0 port
OS Win7，Win8，Win10
PC connected to the sensor(detector) must be approved by local authorities: for example, by IT

equipment safety certificate, NRTL approval, etc..
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3. Information on Operation
3.1 Installation and operation ....................................................................... 18

3.2 Multi-sensor(detector)............................................................................. 18
3.3 Connect Sensor(detector) ........................................................................ 18
3.4 Get the first image .................................................................................. 19
3.5 Create correction templates:.................................................................... 20
3.6 Load template......................................................................................... 21
3.7 Defect template modification ................................................................... 22
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3.1 Installation and operation
This chapter mainly introduces the use of DEMO software iDetector（service engineer） to
connect the sensor(detector) and realize the basic image acquisition and image processing
functions.
The detector is connected to the computer via USB, and the image data is transmitted via USB
protocol.
3.2 Multi-sensor(detector)
Multi sensor(detector)s can be supported by USB ports on PC, or using self-power USB Hub.
It up to 9 sensor(detector)s.
Also, the snesor can be supported to connect by USB-Hub, which can be powered by
computer or external power.
3.3 Connect Sensor(detector)
Double-click to run the “iDetector.exe” in the SDK directory..\Tools\iDetector\x64, to enter

into the Home window, see figure 3.3.1
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Figure 3.3.1 Home interface
Note: select w32 or x64 according to the computer system.
After sensor(detector) is connection successfully, the Acquire tab will be entered, see figure
3.3.2
Figure 3.3.2 Acuire interface
3.4 Get the first image
After the sensor(detector) connected successfully, you can set the AED trigger mode in
Detector interface according to the x-ray device.
Parameters Description Note
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Product No Product number Read only

Serial No Sensor(detector) serial number Read only
Main Version The Firmware version number Read only
Read Version Read only
Set Delay Time（ms） Delay time Set before exposure and only
work in AC mode
Trigger Mode Trigger Mode Three trigger mode: AED_DC,
AED_AC and software.
Trigger Threshold（uGy/s） Trigger threshold Trigger threshold with different

integration time
3.5 Create correction templates:
The creation steps of gain and defect are as follows:
Double-click iDetector.exe to open

image acquisition software, select
detector from the list, select
“Pluto0001X” and click
“Connect”, wait for successful
connection.
Select calibrate tab to enter

template generation page.
1
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Click “Create Gain&Defect” to

enter the template creation
interface.
Click “Start” to enter the template

creation process.
Start to exposure according to the

expected parameters
3
Change the X-ray on time and re-
exposure until the gray value meet
the expected value. Click “Accept”
and enter into next step.
Follow the same step to

accomplish the other 4 steps; after
5 steps finished, click “Generate”
to create template.
4
It is forbidden to move the sensor(detector) during calibration.
3.6 Load template
In “Acquire” interface, select Offset as SWPostoffset, Gain as SWGain and Defect as

SWDefect”. The image so acquired is a full correction diagram.
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CORRECTION TEMPLATE VALIDITY CHECK

The validity of template can be checked in the calibrate interface:
Template type Period of validity

Offset Updated each shot
Gain 1year
Defect 1 year
3.7 Defect template modification
The factory default Defect template is also in CD for the user. User can modify the Defect
template to add new of previously undetected faulty line and dead pixels.
1. Enter the Local File page, click Load File button and select .dft file to open.
2. After opening file, dead pixels and faulty line setting window will pop up as shown in
Figure 3.7.1 below. Type in the coordinate in point area, click Add button to add dead pixels
and click Delete button to delete dead pixels;
3. Type in coordinate values of vertical or horizontal line in Line area, click Add button
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to add faulty line and click Delete button to delete faulty wire;
4. Click Save button to see the modification results in image preview.
Figure 3.7.1 Defect modification window
23 /35
4. Troubleshooting
4.1 Log………………………………………………………..…………………..25
4.2 Quick troubleshooting ............................................................................. 25
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You should know some basic electronic knowledge and computer skill to read this user’s
manual. Users should know how to use iDetector.
If you have any question that not mentioned in this manual, please contact our customer
service department ([email protected]). We will provide you with the best service.
4.1 Log
Users can read the main operation information of the detector from the log. The store path of
log is ..\Tools\iDetector\x64\work_dir\Pluto0001X \detector.log, in debug mode, please set the
Cfg_LogLevel=0 in config.ini for more detail
4.2 Quick troubleshooting
The following table lists the symptom, cause and corrective action.
Symptom Cause Correction active
Can not connect Can not find device No sensor(detector) connection.
sensor(detector) The USB connector is damage.
Re-plug the USB connector.
Change the USB port and re-plug.
Check the cable and sensor(detector) for damage or other
abnormallities.
Reinstall the usb driver.
The USB input voltage is too low and needs to be increased
to more than 4.8V.
It prompts cannot find device Delete the “Cfg_USBConnStr” in ..\

\Tools\iDetector\x64\work_dir\Pluto0001X\config.ini
Delete the “SN” in ..\
\Tools\iDetector\x64\work_dir\Pluto0001X\config.ini
No image display No sensor(detector) connection Check the sensor(detector) and cable.

Sensor(detector) or cable is Increase the distance between tube and sensor(detector).
damged Increase mA.
X-ray dose is too low Increase exposure time.
Exposure time is too short Replug the sensor(detector) and try again.
Image from x-ray The sensor(detector) is moving Fix the sensor(detector) before exposure.
exposure is pale during exposure Check the x-ray machine.
and grainy X-ray is instability Check the sensor(detector) position.
The imaging
surfaceofsensor(detector) is
not facing the x-ray device
If the symptom still exists, please contact the service
25 / 37
5. Information on Safety Regulations
5.1 Medical Equipment Safety Standards ................................................... 27

5.2 Guidance and manufacture’s declaration for EMC ................................ 28
5.3 Environmental Directive ...................................................................... 29
26 / 37
Product regulatory information includes safety, EMC and other related regulation requirements of the
product and its accessories.
5.1 Medical Equipment Safety Standards

 Medical equipment classification
Not Class I equipment;
Protection type against electrical
Not Class II equipment;
shock
Not internally power equipment.
Protection degree against electrical
With type BF applied part
shock
Protection degree against water IP68 (intraoral sensor(detector) part)

penetration IPX0 (control box)
Mode of operation Continuous operation

Not suitable for use in situation with flammable anesthetic mixture with
Flammable anesthetics air, oxygen or nitrous oxide
Not suitable for use in oxygen-rich situation
Both Pluto0001X and Pluto0002X are only one power supply and signal input and output part, both the power
and signal via a USB port to connect to a PC.
 Safety standards reference
Wireless detector safety standards cover the detector, charger, battery pack and other accessories.
IEC 60601 1: 2005 + CORR. 1 (2006) Medical electrical equipment –Part 1: General requirements for basic
+ CORR. 2 (2007) + AM1 (2012) safety and essential performance
EN 60601-1:2006 + A11:2011 + Medical electrical equipment – Part 1: General requirements for basic
A1:2013 + A12:2014 safety and essential performance
ANSI/AAMI ES60601-1:2005/
Medical electrical equipment – Part 1: General requirements for basic
(R)2012 + A1:2012 +
safety and essential performance
C1:2009/(R)2012 + A2:2010/(R)2012
Medical electrical equipment –Part 1: General requirements for basic
CAN/CSA-C22.2 No.60601-1:14
Medical electrical equipment –Part 1: General requirements for basic
KS C IEC 60601-1
Medical electrical equipment - Part 2-65: Particular requirements for
IEC 60601-2-65:2012+A1:2017 the basic safety and essential performance of dental intra-oral X-ray
equipment
Medical electrical equipment Part 1-6: General requirements for basic
IEC 60601-1-6:2010+A1:2013
safety and essential performance — Collateral standard: Usability
CAN/CSA-C22.2 NO. 60601-1- Medical electrical equipment Part 1-6: General requirements for basic
6:11+A1:2015 safety and essential performance — Collateral standard: Usability
KS C IEC 60601-1-6:2011
EN 60601-1-6:2010+A1:2015
Medical electrical equipment – Part 1-2: General requirements for
IEC 60601-1-2:2014 basic safety and essential performance– Collateral standard:
Electromagnetic disturbances– Requirements and tests
27 /37
Medical electrical equipment – Part 1-2: General requirements for

EN 60601-1-2:2015 basic safety and essential performance– Collateral standard:
Electromagnetic disturbances– Requirements and tests
EN 62304:2006/AC:2008 Medical device software – Software life-cycle processes
Medical devices – Application of usability engineering to medical
EN 62366:2008
devices
Medical devices-symbols to be used with medical device labels,
ISO 15223-1:2016
labeling and information to be supplied–Part1:General requirements
5.2 Guidance and manufacture’s declaration for EMC
5.2.1 EMI Compliance Table

 Emissions
Phenomenon Compliance Electromagnetic environment
CISPR 11
RF emissions Professional healthcare facility environment
Group 1, ClassB
5.2.2 EMS Compliance Table

 Enclosure USB Port
Immunity test levels
Phenomenon Basic EMC standard
Professional healthcare facility environment
Electrostatic ±8 kV contact
IEC 61000-4-2
Discharge ±2kV, ±4kV, ±8kV, ±15kV air
3V/m
Radiated RF EM field IEC 61000-4-3 80MHz-2.7GHz
80% AM at 1kHz
Near fields from RF
wireless Refer to table “Near fields from RF wireless
IEC 61000-4-3
communications communications equipment”
equipment
Rated power frequency 30A/m
IEC 61000-4-8
magnetic fields 50Hz or 60Hz
 Near fields from RF wireless communications equipment

Test frequency Band Immunity test levels
(MHz) (MHz) Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m
710
780
810
930
1720
1970
28 /37
5240
5785
 Recommended separation distances between portable or mobile RF communication device and

detector:
Portable RF communications equipment, including antennas, can effect medical electrical equipment.
The warning should include a use distance such as “be used no closer than 30 cm (12 inches) to any part
of the Pluto0001X and Pluto0002X, including cables specified by the manufacturer”.
 Cable provided for EMC

Recommended
Shield/Unshielded Number Cable classification
length
2.8m shielded 1 piece DC power and SIP/SOP
 Electromagnetic Compatibility (EMC)
The Pluto0001X and Pluto0002X digital intraoral X-ray imaging system need special precautions
regarding EMC, and should be installed by authorized personnel and follow EMC guidance in the user
manual. The PlutoX series product when in use may interfere with portable and mobile RF
communication devices such as mobile (cellular) telephones. Electromagnetic interference may result in
incorrect operation of the system and a potentially dangerous situation.
The PlutoX series digital intraoral X-ray imaging system should not be stacked with or adjacent to other
devices. If inevitable, verify the product.
The PlutoX series digital intraoral X-ray imaging system conforms to the IEC60601-1-2:2014 and
EN60601-1-2:2015 standard on both immunity and emissions.
Accessories, transmitters and cables other than those specified by the user manual or sold together with
product may result in increased emissions or decreased immunity of the product.
5.3 Environmental Directive
Europe WEEE directive
ROHS (2011/65/EU)
PFOS legislation (No.757/2010)
REACH legislation (No.1907/2006)
Cadmium legislation (Controlled substance: Annex XVII)
EU Packaging Directive (94/62/EC)
29 /37
6.Product Maintenance
6.1. Expected Service Life .......................................................................... 31

6.2. Regular Inspection and Maintenance .................................................... 31
6.3. Repair ................................................................................................ 31
6.4. Care and Cleaning .............................................................................. 32
30 / 35
6.1. Expected Service Life

Estimated product lifetime is 2 years with regular inspection and maintenance.
6.2. Regular Inspection and Maintenance

The detector needs regular inspection at least once a year not only for the safety of patients, the operator
and third parties, but also for performance and reliability. If necessary, contact service office or local
dealer for regular inspection or maintenance.
In order to ensure the safety of patients, operators or other third parties, and to maintain the good
performance and reliability of the equipment, it is necessary to conduct regular inspections at least once
a year. If necessary, clean up equipment, adjust parameters or replace consumables according to the
safety requirements in the preface of this manual.
6.2.1 Daily inspection
Before and after using, the following check items shall be implement.
Inspection items Inspection actions
Make sure that the detector has no cracks
Intraoral sensor(detector) Ensure that no dust and impurities adhere to the USB
interface
Ensure that the cables are not damaged and the cable
cable
casing is not torn
6.2.2 Monthly and annual inspections

Inspection items frequency Inspection actions
Check the resolution of the
Resolution Monthly/Yearly detector through the resolution
graph or use a phantom
Evaluate by checking the image
Linearity range Monthly/Yearly
gray value
When the X-ray generator, tube,
correction Monthly/Yearly collimator or exposure
environment changes
6.3. Repair
If a problem cannot be solved, contact your sales representative or local dealer. Please provide the
following information:
Product Name:
31 / 35
6. Product Maintenance
Series Number:
Description of Problem: as clearly as possible
6.4. Care and Cleaning

In order to prevent infection, wipe the front plate of the sensor(detector) unit with ethanol to disinfect it
each time a different patient uses the instrument. If you plan to use a disinfectant other than those
specified above, or you are mixing another disinfectant with ethanol, please consult a specialist because it
may damage the plate.
To clean the sensor(detector) shall use the 70% isopropyl alcohol. Please observe the precautions noted.
Do not soak or immerse any part of the Product, and be sure to dry it completely after cleaning.
Clean the surface of the Product by moistening it with a soft cotton swab dipped in one of the cleaning
solution. Gently wipe the surface end-to-end in straight lines, without applying any pressure. Make sure
the liquid does not penetrate the Product through the USB cable or the sensor(detector) cable connectors.
After cleaning the surface of the sensor(detector), use a clean lint-free cloth to dry the Product, as
required, until the surface is clean.
Do not use the following cleaning materials.

●Hard brushes or scrapers of any kind
●Strong acids or alkaloids
32 /37
Appendix
A. Information of Economic Operator ....................................................... 34

B. Recommended exposure time ............................................................... 35
33 / 35
Appendix
A. Information of Economic Operator
COMPANY: iRay Technology Co., Ltd
ADDRESS: Rm. 202, Building 7, No. 590, Ruiqing Rd., Zhangjiang East,
Pudong, Shanghai, China
ZIP CODE: 201201
TELEPHONE: +86-21-50720560
EUROPEAN REPRESENTATIVE
COMPANY: iRay Europe GmbH
ADDRESS: In den Dorfwiesen 14, 71720 Oberstenfeld Germany
TEL: +49-7062-977 88 00
FAX: +49-7062-976 05 71
Email: [email protected]
EUROPEAN IMPORTOR
COMPANY: iRay Europe GmbH
ADDRESS: In den Dorfwiesen 14, 71720 Oberstenfeld Germany
TEL: +49-7062-977 88 00
FAX: +49-7062-976 05 71
34 / 35
Appendix
B. Recommended exposure time
Protocol Patient x-Ray mahcine Exposure time
Child 70kV/8mA 0.032

Incisors
Adult 70kV/8mA 0.040
Premolars and Child 70kV/8mA 0.040

Maxilla
Canines Adult 70kV/8mA 0.050

Molars

Incisors
Premolars and Child 70kV/8mA 0.032

Mandible
Canines Adult 70kV/8mA 0.040

Molars
Note: X-ray sources: 70kV/8mA when using a 20cm SID
Recommended exposure time can vary depending on the patient’s body size, age, sex, and thickness of
the position to be photographed.
Please adjust exposure time according to patient.
 Forlarger body types: increase the source current by25%
 For children(5~21age): reduce the source current (or Exposure time) by20%
 For edentulous patients : reduce the source current by20%.
Since the X-ray exposure condition can be changed depending on the age, gender and bone density of
the patient, in case of Pediatric, X-ray exposure condition can be changed by expert’s judge.
For further information, please refer to FDA Pediatric X-ray Imaging webpage,
http://www.fda.gov/radiation-
emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm)
35 / 35

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Digital Intra-oral X-Ray Imaging System

Document ID: 111-201-02

Release Date: 2019-11-25

Please use it correctly on the basis of full understanding of the content.

Tel: +86 21 50720560

Fax: +86 21 50720561

Location: No.33 Xinggang Road, Taicang Port Economic and Technological

Caring for your environment

Recycling iRay Equipment

Symbols and Conventions

This symbol is used to identify conditions under which

This notice is used to identify conditions under which

This notice is used to identify conditions under which

This is used to indicate a prohibited operation.

This is used to indicate an action that must be performed.

This is used to indicate important operations and

This is used to indicate operations for reference and

Labels and markings on the equipment

Caution: please refer to the instructions in the user manual.

This symbol is used to identify the manufacture’s series number

This symbol is used to indicate the name, address of the

This symbol is used to indicate the name and address of iRay

This symbol is used to indicate consultation of the user guide for

Type BF applied part

IP68 IP Grade of the sensor(detector) according to IEC60529

Caution: Federal law restricts this device to sale by or on the order of

Package symbol, fragile, handle with care

Package symbol, keep away from rain

Package symbol, keep away from sunlight

Package symbol, stacking limit by number, it shows the maximum

Package symbol, indicates the package shall be stored, transported,

Package symbol, indicates the range of humidity to which the

This symbol indicates the item is a medical device.

Unique Device Identifier

This symbol is used to indicate that the equipment has passed.

1. Safety Information ............................................................................................6

1.1 Safety precautions..................................................................................... 7

1.1 Safety precautions

The sensor(detector) is used in conjunction with the registered x-ray machine.

1.2 Notes for Using

 When the sensor(detector) is working, the temperature of the sensor(detector) will

1.3 Storage and Operation Environment

Operation 10~35℃ ≤1℃/min 20~90% RH ≤10 mbar/hour

2.1 Indications for Use ................................................................................. 11

2.1 Indications for Use

trained professionals under the guidance of doctors.

2.2 Component of the imaging system

2.2.1 Image acquisition workstation (optional)

management, examination management, image storage and image printing administration.

Fig.1 Pluto0001X outline（unit: mm）

Fig.2 Pluto0002X outline（unit: mm）

Item Detailed information

Pixel matrix 1500×1000 1800×1300

Pixel Pitch 20μm

Scintillation Screen CsI

Sensor(detector) size 38.5mm×25mm×5mm 40mm× 31mm×5mm

Trigger sensitivity <100μGy/s

Max linearity dose >400uGy

Length of cable ＜3m